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"Salvage Use" of Recombinant Factor VIIa After Inadequate Haemostasis in Complex Cardiac Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Austin Health.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Austin Health
ClinicalTrials.gov Identifier:
NCT00214656
First received: September 14, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

Aims and Hypotheses:

This randomised placebo controlled study will test the hypothesis that Recombinant Activated Factor VII (rVIIa) will improve haemostasis after an inadequate response to conventional therapy in complex cardiac surgery.

Major bleeding is still of concern in complex cardiac surgery. It has been shown to be associated with poorer patient outcome and results in the consumption of resources (hospital costs, manpower and blood bank reserves). This study has the potential to provide evidence that rVIIa can reduce transfusion requirements and improve patient outcome in a problematic aspect of complicated cardiac surgery.

The objective is to conduct a multi-centre randomised placebo controlled study that has been designed to scientifically evaluate the treatment of post bypass coagulopathy in the association with complex cardiac surgery. The trial design is based on clinical practice that has evolved over 2 years at the Austin Hospital during which 38 patients have received open label administration of rVIIa. There is currently no published RCT in this area and there is no TGA approval for the use of rVIIa for this indication.


Condition Intervention Phase
Myocardial Ischemia
Blood Coagulation Disorders
Coronary Artery Disease
Heart Valve Diseases
 Drug: Recombinant Activated Factor VII
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: "Salvage Use" of Recombinant Activated Factor VII After Inadequate Haemostatic Response to Conventional Therapy in Complex Cardiac Surgery - a Randomised Placebo Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Austin Health:

Primary Outcome Measures:
  • Adequate haemostasis to enable chest closure after administration of trial medication without the need for further intervention to improve coagulation.

Secondary Outcome Measures:
  • Percentage of cases that haemostasis after first administration of coagulation factors alone
  • Assessment of surgical field after administration of trial medication
  • Time to closure of chest after administration of trial medication
  • Transfusion requirements in post bypass period in theatre
  • Transfusion requirements in ICU first 12 hours
  • Mediastinal drainage in ICU first 12 hours
  • Coagulation study results at various sample times
  • Requirement for chest re-exploration
  • Ventilation duration in ICU
  • Duration of stay in ICU

Estimated Enrollment: 40
Study Start Date: June 2005
Estimated Study Completion Date: June 2008
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with scheduled cardiac surgery undergoing the following procedures
  • Double valve replacements or repair.
  • Major thoracic aortic surgery including hypothermic circulatory arrest or descending aortic reconstruction.
  • Valve repair or replacement in the setting of endocarditis
  • Complex procedures requiring cardiopulmonary bypass duration anticipated to exceed 180 minutes in patients aged ³70 years

Exclusion Criteria:

  • Patient unable to give informed consent
  • Patient refusal
  • Allergy to rVIIa
  • Allergy to aprotinin or prior exposure within 6 months
  • Pre-existing congenital coagulopathy
  • Pre-existing hypercoagulable state
  • Patients in inclusion criteria whose actual bypass time does not exceed 180 minutes
  • Unresolved surgical bleeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00214656

Contacts
Contact: Peter McCall, FANZCA 61 3 94965000 ext 3800 peter.mccall@austin.org.au
Contact: stephanie j Poustie, MPH 61 3 94965000 ext 3800 stephanie.poustie@austin.org.au

Locations
Australia, Victoria
Austin Health Recruiting
Melbourne, Victoria, Australia, 3084
Contact: Peter McCall, FANZCA     61 3 94965000 ext 3800     peter.mccall@austin.org.au    
Contact: Stephanie J Poustie, MPH     61 3 94965000 ext 3800     stephanie.poustie@austin.org.au    
Principal Investigator: Peter McCall, FANZCA            
Sponsors and Collaborators
Austin Health
Investigators
Principal Investigator: Peter McCall, FANZCA Staff Anaesthetist
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00214656     History of Changes
Other Study ID Numbers: H2005/02047
Study First Received: September 14, 2005
Last Updated: September 14, 2005
Health Authority: Australia: National Health and Medical Research Council

Keywords provided by Austin Health:
Cardiac surgical procedures
Surgical blood loss
Surgical haemostasis
Factor VIIa
Anaesthesia

Additional relevant MeSH terms:
Heart Valve Diseases
Blood Coagulation Disorders
Hemostatic Disorders
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Ischemia
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
 Hemorrhagic Disorders
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013